Quality Engineer

STERIS; Swindon; On-site; GBP 45,000 - 65,000; Full time

Job summary

STERIS AST is recruiting a Quality Engineer to strengthen our quality and regulatory functions. The role involves reviewing processing files for new products, ensuring release criteria are met, and maintaining calibration and records in line with QSR/cGMP expectations.

You will support internal audits, customer/regulatory audits, and drive continuous improvement through corrective actions, training, and documentation in a fast-paced manufacturing environment.

Qualifications

• Minimum 3 years professional experience in regulatory affairs, quality systems or related fields.
• Ability to read, write and communicate in English.
• Experience with internal auditing and compliance matters is preferred.

Responsibilities

• Performs review of processing files for new product or specification requirements to ensure processing parameters are met and approves product release.
• Reviews operating logs and calibration records to ensure timely, accurate documentation and compliance.
• Maintains and revises AST quality systems; writes deviations and responses; supports regulatory and customer audits.
• Develops corrective actions in response to deviations, complaints or audits and creates training materials.
• Prepares internal assessment reports and supports continuous improvement projects across the facility.
• Monitors quality data and implements improvement plans; participates in safety and regulatory compliance activities.

Skills

Regulatory affairs

Quality systems

Internal auditing

English proficiency

Analytical skills

Job description

HOW YOU WILL MAKE A DIFFERENCE

Do you want to spend your working time making a difference in the world around you? Are you passionate about supporting the medical and pharmaceutical industries? Do you care about keeping patients and people safe? If so, then a career with Steris AST could be a great fit for you.

About You

Do you want to spend your working time making a difference in the world around you? Are you passionate about supporting the medical and pharmaceutical industries? Do you care about keeping patients and people safe? If so, then a career with Steris AST could be a great fit for you.

About Us

At Steris AST we are the trusted experts in neutral sterilization offering includes radiation and gas technologies. We offer electron beam, gamma, X-ray, ethylene oxide and vaporized hydrogen peroxide technologies for the purpose of product sterilization. Whether that product be a single use medical instrument, a hospital environment, cosmetics and toiletries, or food products, we make sure that everything that makes its way to an end user is safe for use or consumption.

We are currently recruiting for a Quality Engineer vacancy. This is an excellent opportunity to join the business at a skilled professional level and help us maintain and build on the excellent quality

What Is Involved

• Performs review of processing files for a new product or new specification requirements after product processing and prior to product release in order to ensure processing parameters have been met. To be responsible for product release for all processing at the site.
• Performs or facilities the review of operating logs (spectrophotometer etc.) to ensure timely and accurate record keeping.
• Performs or facilities the review and maintenance of calibration records to ensure calibration is performed in a timely manner.
• Establishes or facilities the establishment of appropriate policies and procedures as well as revisions and maintenance of AST quality Systems
• Writes or assists in the writing of deviation and responses to deviations as well as documenting Customer concerns based on established Customer specification and AST policies and procedures.
• Develops corrective actions as required by process deviation, procedure deviations, complaints, regulatory audits, Customer audits and internal audits, and develops training materials and trains employees in response to procedural changes, policy changes and improvement activities.
• Prepares or facilities the preparation of the monthly internal assessment report.
• Manages and provides deliverable or special projects such as procedure revisions. Develops vehicle and tools and concludes analysis or relevant metrics to identify areas for continuous improvement.
• Provides support in form of data, documentation and feedback for Customer and/or regulatory audits, notified body audits as well as internal audits.
• Performs internal audits at the facility and other facilities as required.
• Monitors and trends data relative to the Quality systems and makes recommendations for improvements as well as establishes implementation plans
• Maintains professional skills, knowledge and abilities by attending educational workshops, reviewing professional publications and participating in professional societies.
• Support the continuous improvement efforts within the facility by participating in quality and performance improvement projects. Provide feedback from quality staff to the Senior Quality Manager, Regional Quality Manager, Quality Manager as applicable AST and Quality and Regulatory Compliance Management on opportunities for improvement.
• Support a safe, clean and secure working environment by supporting procedures, rules and regulations; supports plant safety committees that evaluate plant machinery, equipment and working conditions.
• Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
• Exhibits a commitment to the AST shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer’s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer’s needs with a sense of urgency.
• Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP, Lean principles and other directives; supports the directives and decisions of higher-level management and performs other duties as assigned.

Required Experience

• Minimum of 3 years professional experience, preferably including regulatory affairs, legal or governmental compliance matters, quality systems, internal auditing, applicable scientific or technical functions and/or healthcare industry experience.
• Requires ability to effectively read, write and verbally communicate in English.
• Requires working independently under general guidance and supervision.
• Requires effective interpersonal skills as demonstrated through prior experience .
• Computer skills and work processing spreadsheet and software capabilities.
• Requires above average organizing, analyzing and math skills (practical application od fractions, percentage, ratio, proportions, measurement and basic algebra) to determine organizational, Customer and Regulatory problems and formulate corrective action plan.
• Attention to details.
• Able to adapt to changing duties and responsibilities.
• Able to influence people in the opinions, attitude or judgments, evaluate and decide, to adapt to situations under stress.

Knowledge Of

• 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
• 21 CFR Section 1271.150 – Current Good Tissue Practice (cGTP)
• 21 CFR Part 11 – Electronic Records, Electronic Signatures
• Health Canada, Food and Drug Regulations, Division 2, Part C: Good Manufacturing Practices - Drugs
• ISO 13485: Medical devices – Quality management systems,
• ISO 17025: General requirements for the competence of testing and calibration laboratories
• ISO 9001 Current Certified Version, Quality Management Systems – Requirements
• Volume 4 Good Manufacturing Practice (GMP) Guidelines – EU GMP
• MHLW Ministerial Ordinance No. 169, 2004 of the Japanese Pharmaceutical Affairs Law (PAL).

Equal Opportunities

STERIS plc provides employment and advancement opportunities without regard to age, disability, gender reassignment, marriage or civil partnership, pregnancy and maternity, race, religion/belief, sex (gender), sexual orientation or any other legally protected characteristic as defined by UK employment law. The Company bases all employment decisions on merit, qualifications, skills, and abilities with the intention that the best candidate is selected for each position

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com.

STERIS strives to be an Equal Opportunity Employer.